1. Field
Disclosed is a composition for the stabilization of protein drugs, including a surfactant and having pH ranging from greater than about 4.5 to about 8, a liquid formulation including a protein drug and the composition, and a method of stabilizing a protein drug using the composition.
2. Description of the Related Art
Protein preparations are prone to degradation due to the denaturation and aggregation of proteins during the production process of the preparations. It is believed that the instability of protein preparations is mainly caused by the formation of soluble/insoluble particles, and increases with storage time. In general, important matters to consider in the formulation of a protein drug are maintaining solubility, stability, and bioactivity of the protein.
Among protein drugs, immunoglobulins are relatively liable to form aggregates and particulates, and thus have the disadvantage of deterioration in stability when they are formulated into a liquid form for intravenous or subcutaneous injections. Such aggregation and particulation (formation of particulates) of proteins and subsequent decreases in the stability thereof are aggravated when protein drugs such as immunoglobulins or antibodies are formulated at high concentrations, giving rise to a great hindrance in the development of protein drug products.
There is therefore a need for developing a technology for maintaining and/or improving physical, chemical and biological stability of protein drugs by preventing proteins from forming aggregates and/or particulates in liquid formulations thereof.